Director, Design Quality & Site Assurance

RXinsider LTD.; Andover (MA); Hybrid; USD 185,000 - 205,000; Full time

Benefits offered by this job

Medical, dental and vision coverage

Life insurance

Disability insurance

401K with company contribution

Wellness program

Job summary

Fresenius Kabi in North Andover MA is seeking a Director of Design Assurance & Site Quality to lead the local Quality organization, own the Design Center's QMS, and serve as Site Quality Management Representative. Responsibilities include Design Controls, Risk Management, Design Transfer, supplier quality, and audit readiness.

The role drives design robustness, manufacturability, and continuous improvement, ensuring products are safe, effective, and compliant throughout their lifecycle.

Qualifications

• Experience with Infusion Pumps, Sets and Systems preferred but not required.
• Deep knowledge of US and global regulatory requirements (FDA QSR, ISO 13485, MDR/IVDR).
• Proven ability to lead Quality Systems, CAPA, change control and audits.

Responsibilities

• Lead the site Quality organization and manage Design Assurance, QMS, and related functions.
• Drive Design Controls, Risk Management, DfX, Design Transfer and Supplier Quality.
• Ensure FDA inspections and Notified Body audits readiness and compliance.
• Oversee CAPA, document control, training effectiveness, and management reviews.
• Collaborate with R&D, PMS, Regulatory Affairs, Manufacturing Sites and Market Units.
• Provide technical Quality leadership to post-market performance and field issues.

Skills

Infusion pumps knowledge

Regulatory knowledge

FDA inspections

Quality systems

Leadership

Cross-functional collaboration

Job description

Fresenius Kabi in North Andover MA is seeking a Director of Design Assurance & Site Quality to lead the local Quality organization, own the Design Center's QMS, and serve as Site Quality Management Representative. Responsibilities include Design Controls, Risk Management, Design Transfer, supplier quality, and audit readiness.

The role drives design robustness, manufacturability, and continuous improvement, ensuring products are safe, effective, and compliant throughout their lifecycle.